November 5, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Even the slightest quality failures can lead to product recalls. Keep your guard up against recalls by learning about their primary causes, how the FDA classifies them, the four critical steps of recall response, and smart approaches that can help you avoid them altogether.
Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.
March 18, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
There are so many similar terms related to quality in the life sciences, it’s easy to get confused about their purposes and intersections. Learn the specific roles of quality assurance, quality control, and quality management, how they overlap, and the differences between each critical function.
March 10, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
If your medical device company is planning to implement quality management system software, you can’t afford to overlook the 10 most important capabilities an EQMS solution should have. Get the facts about EQMS software before you invest.
January 20, 2022
By Regina Fullin, Vice President of RA/QA Consulting, Compliance Team
No pharma company wants to fail an inspection, and yet it’s common for these five mistakes to interfere with compliance efforts. Industry expert Nicole Cannon offers tips on how to avoid them along with insight into how digitization can be part of the solution. Follow her advice to get safe, effective products to market quickly.
August 11, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.
March 26, 2020
By Sarah Beale, Staff Writer, MasterControl
In honor of Leonard Nimoy’s birthday, we’ve taken some of Spock’s words of wisdom and applied them to manufacturing. Because it’s only logical to get paper off the shop floor and fully digitize your processes.
May 1, 2019
By Sara Bresee, Managing Director of APAC, MasterControl
Beginnings are important because they often give a first impression. Today is a landmark day for MasterControl as we introduce not just our new look and feel, but also a renewed commitment to customers and an integrated platform of enterprise solutions. Today changes everything because #QualityChangesEverything.
August 2, 2018
By Sarah Beale, Staff Writer, MasterControl
Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.
July 31, 2018
By Tifany Desprez, Apsalys, a MasterControl Partner
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
June 5, 2018
By Marci Crane, Staff Writer, MasterControl
Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.
May 29, 2018
By Philippe Charbon, President, Apsalys
The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.
November 29, 2016
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”
May 29, 2014
By James Jardine, GxP Lifeline Editor, MasterControl
Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.
.webp?sfvrsn=e33953cc_1 "Guide-to-Recall-Avoidance_image_132x132 (1)")
